Pelvic Organ ProlapsePOETRYNCT02548858
Perineorrhaphy Outcomes Related to Body Imagery
A study testing Perineorrhaphy and No Perineorrhaphy in people with Pelvic Organ Prolapse, run by University of New Mexico at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether performing a perineorrhaphy during a reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body image. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Perineorrhaphy and No Perineorrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to 1 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects ≥ 18 years of age
- Symptomatic POP who desire vaginal or abdominal apical suspension
- English-speaking/reading
- Genital hiatus measurement < 6 cm, >2cm
Who cannot join
- Those who desire colpocleisis
- Those whose surgical planning includes levatorplasty
- Genital hiatus measurements greater than or equal to 6 cm, < 2 cm
- Inability to speak/understand English
- Those who specifically request a perineorrhaphy
- Pregnant patients
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico
Albuquerque, New Mexico, 87131
Sandoval Regional Medical Center
Rio Rancho, New Mexico, 87144
About this study
Official title: Perineorrhaphy Outcomes Related to Body Imagery (POETRY)
The purpose of this study is to determine whether performing a perineorrhaphy during a reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body image.
Read the detailed description
The objective of this study is to assess the body image of women before and after pelvic reconstructive surgery with and without perineorrhaphy to examine if a perineorrhaphy impacts postoperative body image by conducting a single-blind, randomized controlled clinical trial. The central hypothesis is that patients' body image will not be affected by whether or not a perineorrhaphy is performed.
The target population are those patients with POP who are planning an apical prolapse repair. All participants will give written consent prior to their surgery. After enrollment, women will fill out baseline surveys, including the Body Image in Pelvic Organ Prolapse (BIPOP), the Pelvic organ prolapse/Incontinence Sexual Questionnaire, IUGA-revised) (PISQ-IR), the Pelvic Floor Distress Inventory (PFDI-20), and a Pain Visual Analog Scale (VAS) to assess baseline pain. Additionally, participants will undergo a Pelvic Organ Prolapse Quantification (POP-Q) examination with the addition of measurements of genital hiatus (GH) and perineal body (PB) lengths without strain. The other measurements involved in the POP-Q entail assigning numerical values to descent of different parts of the vagina. Pelvic floor muscle strength will be measured using a Peritron™ perineometer and Kegel strength (contraction of the pelvic floor muscles) using the Oxford grading scale.
On the day of the patient's surgery, the surgeon will call a research coordinator who will open the next envelope in the sequence randomizing the patient to perinorrhaphy or to no perineorrhaphy. Randomization assignment will be generated by a computer-based randomization table and assigned by a research coordinator not otherwise involved in the study. Women will not be informed to what arm of the study they were randomized, and postoperative assessments will be made by individuals not involved with the patient's surgery.
At prescribed time points post-operatively, the patients will be assessed by POP-Q, genital hiatus and perineal body measurements performed with and without strain, the pain VAS, the BIPOP, The PISQ-IR, the PFDI-20, and pelvic floor muscle strength via the Oxford scale and measurement by the Peritron™ perineometer.
The investigators' aims for this study are:
Aim #1: To determine if a patient's body image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at the time of pelvic organ prolapse surgery. Hypothesis: There will be no difference in body image scores between those with and without concomitant perineorrhaphy.
Aim #2: To determine if Pelvic Organ Prolapse Quantification (POP-Q) measurements are affected by a perineorrhaphy. Hypothesis: After a perineorrhaphy, the genital hiatus (GH) will be smaller, the total vaginal length (TVL) will be longer, the perineal body (PB) will be longer, and all others will be unaffected when compared to those in whom perineorrhaphy is not performed.
Aim #3: To determine if the strength of pelvic floor muscles is improved after corrective pelvic organ prolapse surgery with a perineorrhaphy compared with those patients who did not have a perineorrhaphy, as measured by the Peritron™, a perineometer device that measures pelvic floor muscle contraction strength. Hypothesis: Pelvic floor muscle strength will be unaffected by the performance of a perineorrhaphy.
Aim #4: To assess if those having a perineorrhaphy have higher postoperative pain both in the short term and long term by using a visual analog scale (VAS) both in the immediate and 6 week postoperative period. Hypothesis: Those with perineorrhaphies will report more pain on a VAS both immediately and 6 weeks post-surgery.
Aim #5: To describe if there are differences in sexual function after corrective pelvic organ prolapse with a perineorrhaphy compared to those who did not undergo a perineorrhaphy. Hypothesis: Sexual function will be improved after POP surgery repair but will be unaffected by the performance of a perineorrhaphy.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Perineorrhaphy, No Perineorrhaphy
- Keywords
- Perineorrhaphy, Pelvic organ prolapse, Vaginal or abdominal reconstruction, Body image
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerineorrhaphyProcedure or surgery
Those patients who are randomized to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse.
No PerineorrhaphyProcedure or surgery
Those patients who are randomized not to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse.
| Study group | Role | What they receive |
|---|---|---|
| Perineorrhaphy | Active comparator | Patients who are randomized to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure Receives: Procedure: Perineorrhaphy |
| No Perineorrhaphy | Active comparator | Patients who are randomized not to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure Receives: Procedure: No Perineorrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire
To determine if a patient's body image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at the time of pelvic organ prolapse surgery.
Measured: 6 weeks post-operatively
Secondary outcomes (4)
Pelvic Organ Prolapse Quantification (POP-Q) Measurements
To determine if POP-Q measurements are affected by a perineorrhaphy, as measured immediately post-operatively, and at 1 week, 6 weeks and 3 months after surgery.
Measured: Pre-operatively, in the operating room, 1 week, 6 weeks, and 3 months post-operatively
Pelvic Floor Muscle Strength as measured by the Peritron™ perineometer and digitally.
To determine if the strength of pelvic floor muscles is improved after corrective pelvic organ prolapse surgery with a perineorrhaphy compared with those who did not have a perineorrhaphy, as measured by the Peritron™ perineometer and digitally.
Measured: 6 weeks post-operatively
Post-operative Pain by using a pain visual analog scale
To assess if those having a perineorrhaphy have higher post-operative pain both in the short term and long term by using a pain visual analog scale both in the immediate and 6 week post-operative period.
Measured: 6 weeks post-operatively
Sexual Function, as measured by the validated questionnaire, PISQ-IR
To describe if there are differences in sexual function after correction of pelvic organ prolapse with a perineorrhaphy compared to those that did not undergo a perineorrhaphy. The PISQ-IR is a validated questionnaire that measures sexual function in women with pelvic floor disorders in domains such as arousal, orgasm, partner-related issues, sexual quality, desire, and takes into account those who are not sexually active. The patients will fill out this questionnaire at a baseline visit and at post-operative visits.
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startAug 2015
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cara Ninivaggio, University of New Mexico
- Investigators
- Cara S Ninivaggio, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548858
- Sponsor's protocol ID
- 15-108
- Acronym
- POETRY
- Status last verified
- Mar 2019
- First submitted
- 8 Sep 2015
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ninivaggio CS, Komesu YM, Jeppson PC, Cichowski SB, Qualls C, Qeadan F, Rogers RG, Dunivan GC. Perineorrhaphy Outcomes Related to Body Imagery: A Randomized Trial of Body Image Perception. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):281-288. doi: 10.1097/SPV.0000000000000841.
PubMed 32205557
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineorrhaphy Outcomes Related to Body Imagery (POETRY)
- ClinicalTrials.gov ID
- NCT02548858
- Acronym / sponsor ID
- POETRY / 15-108
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Perineorrhaphy, Pelvic organ prolapse, Vaginal or abdominal reconstruction, Body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether performing a perineorrhaphy during a reconstructive surgery indicated for pelvic organ prolapse (POP) affects a patient's body image.
Detailed description
The objective of this study is to assess the body image of women before and after pelvic reconstructive surgery with and without perineorrhaphy to examine if a perineorrhaphy impacts postoperative body image by conducting a single-blind, randomized controlled clinical trial. The central hypothesis is that patients' body image will not be affected by whether or not a perineorrhaphy is performed.
The target population are those patients with POP who are planning an apical prolapse repair. All participants will give written consent prior to their surgery. After enrollment, women will fill out baseline surveys, including the Body Image in Pelvic Organ Prolapse (BIPOP), the Pelvic organ prolapse/Incontinence Sexual Questionnaire, IUGA-revised) (PISQ-IR), the Pelvic Floor Distress Inventory (PFDI-20), and a Pain Visual Analog Scale (VAS) to assess baseline pain. Additionally, participants will undergo a Pelvic Organ Prolapse Quantification (POP-Q) examination with the addition of measurements of genital hiatus (GH) and perineal body (PB) lengths without strain. The other measurements involved in the POP-Q entail assigning numerical values to descent of different parts of the vagina. Pelvic floor muscle strength will be measured using a Peritron™ perineometer and Kegel strength (contraction of the pelvic floor muscles) using the Oxford grading scale.
On the day of the patient's surgery, the surgeon will call a research coordinator who will open the next envelope in the sequence randomizing the patient to perinorrhaphy or to no perineorrhaphy. Randomization assignment will be generated by a computer-based randomization table and assigned by a research coordinator not otherwise involved in the study. Women will not be informed to what arm of the study they were randomized, and postoperative assessments will be made by individuals not involved with the patient's surgery.
At prescribed time points post-operatively, the patients will be assessed by POP-Q, genital hiatus and perineal body measurements performed with and without strain, the pain VAS, the BIPOP, The PISQ-IR, the PFDI-20, and pelvic floor muscle strength via the Oxford scale and measurement by the Peritron™ perineometer.
The investigators' aims for this study are:
Aim #1: To determine if a patient's body image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at the time of pelvic organ prolapse surgery. Hypothesis: There will be no difference in body image scores between those with and without concomitant perineorrhaphy.
Aim #2: To determine if Pelvic Organ Prolapse Quantification (POP-Q) measurements are affected by a perineorrhaphy. Hypothesis: After a perineorrhaphy, the genital hiatus (GH) will be smaller, the total vaginal length (TVL) will be longer, the perineal body (PB) will be longer, and all others will be unaffected when compared to those in whom perineorrhaphy is not performed.
Aim #3: To determine if the strength of pelvic floor muscles is improved after corrective pelvic organ prolapse surgery with a perineorrhaphy compared with those patients who did not have a perineorrhaphy, as measured by the Peritron™, a perineometer device that measures pelvic floor muscle contraction strength. Hypothesis: Pelvic floor muscle strength will be unaffected by the performance of a perineorrhaphy.
Aim #4: To assess if those having a perineorrhaphy have higher postoperative pain both in the short term and long term by using a visual analog scale (VAS) both in the immediate and 6 week postoperative period. Hypothesis: Those with perineorrhaphies will report more pain on a VAS both immediately and 6 weeks post-surgery.
Aim #5: To describe if there are differences in sexual function after corrective pelvic organ prolapse with a perineorrhaphy compared to those who did not undergo a perineorrhaphy. Hypothesis: Sexual function will be improved after POP surgery repair but will be unaffected by the performance of a perineorrhaphy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineorrhaphy | Active comparator | Procedure: PerineorrhaphyPatients who are randomized to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure |
| No Perineorrhaphy | Active comparator | Procedure: No PerineorrhaphyPatients who are randomized not to receive a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥ 18 years of age
- Symptomatic POP who desire vaginal or abdominal apical suspension
- English-speaking/reading
- Genital hiatus measurement < 6 cm, >2cm
Key exclusion criteria (6 listed)
- Those who desire colpocleisis
- Those whose surgical planning includes levatorplasty
- Genital hiatus measurements greater than or equal to 6 cm, < 2 cm
- Inability to speak/understand English
- Those who specifically request a perineorrhaphy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerineorrhaphyThose patients who are randomized to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse. | Procedure or surgery | Perineorrhaphy |
| No PerineorrhaphyThose patients who are randomized not to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse. | Procedure or surgery | No Perineorrhaphy |
Primary outcome
Body Image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire
Time frame: 6 weeks post-operatively
To determine if a patient's body image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire, is affected by concomitant performance of a perineorrhaphy at the time of pelvic organ prolapse surgery.
4 secondary outcomes
Pelvic Organ Prolapse Quantification (POP-Q) Measurements
Time frame: Pre-operatively, in the operating room, 1 week, 6 weeks, and 3 months post-operatively
Pelvic Floor Muscle Strength as measured by the Peritron™ perineometer and digitally.
Time frame: 6 weeks post-operatively
Post-operative Pain by using a pain visual analog scale
Time frame: 6 weeks post-operatively
Sexual Function, as measured by the validated questionnaire, PISQ-IR
Time frame: 3 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Derived from this study: PubMed 32205557Ninivaggio CS, Komesu YM, Jeppson PC, Cichowski SB, Qualls C, Qeadan F, Rogers RG, Dunivan GC. Perineorrhaphy Outcomes Related to Body Imagery: A Randomized Trial of Body Image Perception. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):281-288. doi: 10.1097/SPV.0000000000000841.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cara S Ninivaggio, MD principal investigator
University of New Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineorrhaphy and No Perineorrhaphy in people with Pelvic Organ Prolapse, run by University of New Mexico at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Image, by using the Body Image in Pelvic Organ Prolapse (BIPOP) questionnaire (time frame: 6 weeks post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02548858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.